中成药妇科养坤丸质量标准研究

Quality Standard of Fuke-yangkun Pill

目的建立妇科养坤丸的HPLC定量和TLC定性指纹图谱．方法用TLC对妇科养坤丸中主药木香、香附、白芍、延胡索进行定性鉴别；用HPLC测定妇科养坤丸中黄芩苷的质量分数．结果TLC特征图谱能很好地检测本品的质量；HPLC测得本品中的特征图谱，可确定黄芩苷的质量分数在0．1352～1．3520ug与峰面积呈良好的线性关系，r=0．9998，平均回收率为97．50％（n=5），RSD为1．9％．结论建立的特征图谱能准确、快速地进行定性、定量检测，可用于该制剂质量控制．

Objective To set up quantitative measure of Fuke-yangkun pill by HPLC and qualitative specific spectrum of TLC. Method To differentiate qualitatively the main gradients of Muxiang, Xiangfu, Baishao and Yanhusuo in Fuke-yangkun pill by using TLC;to measure the mass fraction of Baicalin in Fuke-yangkun pill by using HPLC. Results The drug can be detected dramatically by TLC;The content of Baicalin in Fuke-yangkun pill can be determined by using HPLC. It shows a good linear relation with peak area and range from 0. 135 2 - 1. 352 0 ug, r is 0. 999 8, the average recovery rate is 97.50% （ n = 5 ） , RSD is 1.9%. Conclusion The characteristic spectrum is a rapid and accurate method for quantitative and qualitative measurement for control of the preparation.